CEO Presentation to AGM - Dr Ken Taylor 19 November 2020 www.lctglobal.com CONFIDENTIAL
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CEO Presentation to AGM
Dr Ken Taylor
19 November 2020
www.lctglobal.com
CONFIDENTIAL
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
SAFE HARBOUR STATEMENT
This document contains certain forward-looking statements, relating to LCT’s business, which can be identified by the use of
forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”,
“estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could
be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or
potential future sales of product candidates.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to
be materially different from any future results, performance or achievements expressed or implied by such statements.
There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’
requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be
approved by any health authorities for sale in any market or that they will reach any particular level of sales.
In particular, management’s expectations regarding the approval and commercialisation of the product candidates could be affected
by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data;
unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and
additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and
business prospects.
Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may
vary materially from those described herein as anticipated, believed, estimated or expected.
LCT is providing this information as of the date of this presentation and, subject to law, does not assume any obligation to update
any forward-looking statements contained in this document as a result of new information, future events or developments or
otherwise.
CONFIDENTIAL
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
AGENDA
Cash Position 2020 Update
LC-002 for Migraine
LP-003 for Obesity
NTCELL® for Parkinson’s Disease
DIABECELL®
Next Steps
CONFIDENTIAL 3
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
2019 AGM – LCT CASH POSITION
2020 Update
Dec 2019 approx. NZD 4 million
* Dec 2020 approx. NZD 2 million
Callaghan Innovation Grant extended to Mar 2021
20% Rebate on Research Spend
* 2020: approx. NZD392k
Approx. NZD700k/yr (as a going concern)
* 2020: Approx. NZD550k
Cash Runway to approx. Mar 2021 (dependent on projects)
* September 2021 without projects
Complete obesity and migraine clinical proof of principle and out-license
* Complete migraine pre-clinical and if positive data, Phase 1 clinical 2021
NTCELL® – feasibility of larger clinical efficacy study
Partnership
*?
CONFIDENTIAL 4
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal
LC-002 FOR MIGRAINE
CONFIDENTIAL 5
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalCGRP STRONGLY LINKED TO MIGRAINE
Calcitonin Gene-Related Peptide (CGRP) – 37 amino acid neuropeptide
Found in sensory nerves
Modulates pain
Levels are higher in migraine sufferers
CGRP triggers migraine
Nerve cell CGRP
Drug binds Receptor
CGRP or Russo Annual Review of Pharmacology & Toxicology 2015, 55:533-552
CGRP Signal
receptor blocked
Reduced response – less pain
Antagonists needed to treat migraine
CONFIDENTIAL 6
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalMIGRAINE
ADVANCED TREATMENTS BLOCKING CGRP
ARE BEING LAUNCHED
Antibodies that block CGRP activity:
Monthly or quarterly injections,
subcutaneous or intravenous
depending on the drugs
https://migrainepal.com/cgrp-antibodies-migraine/
Small molecule antagonists that block CGRP activity:
Atogepant (in clinical trials)
Vazegepant (in clinical trials)
CONFIDENTIAL 7
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalPUBLICATIONS AND PATENTS
Yang S-H, Harris PWR, Williams GM, Brimble MA. Lipidation of Cysteine or
Cysteine‐Containing Peptides Using the Thiol‐Ene Reaction (CLipPA). Eur. J. Org.
Chem.2016, 2608–2616
Williams ET, Harris PWR, Jamaluddin MA, Loomes KM, Hay DL, Brimble MA. Solid-
Phase Thiol–Ene Lipidation of Peptides for the Synthesis of a Potent CGRP Receptor
Antagonist. Angew Chem Int Ed. 2018,57: 11640–11643
Lu BL, Loomes KM, Hay DL, Harris PWR, Brimble MA. Synthesis of isotopically labelled
αCGRP8-37 and its lipidated analogue. J. Labelled Comp Radiopharm. 2020, 63: 325-
332
Harris PWR, Loomes KM, Hay DL, Jamaluddin A, Walker CS, Williams ET, Brimble MA.
06 November 2018. Peptide Conjugate CGRP Receptor Antagonists and Methods of
Preparation and Uses Thereof. WO2019/087161 A1
National Phase Filing
Brimble MA, Dunbar PR, Williams GW, Verdon D. Amino Acid and Peptide Conjugates
and Uses Thereof. PCT International Patent WO2016/103192 30 Jun 2016.
(Application Number PCT/IB2015/059901, filed 22 Dec 2015) United States Patent
Application 15/535,956, 2018, Published 04 Jan 2018
CONFIDENTIAL 8
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalPOINT OF DIFFERENCE
“to perform better than a triptan, a new acute treatment
should have a faster onset, a longer duration of action,
improved response and relapse rates, and a lower
incidence of drug-induced side effects.”1
1Andrea Negro, Paolo Marelletti. Gepants for the treatment of migraine. Expert Opin Investig Drugs. 2019
Jun;28(6):555-567.
Extended activity at CGRP receptor sites
Also blocks CGRP activation of Amylin1 receptor site
Lipidation extends half life and protects peptide from proteolytic
degradation
No side effects – Derivative of natural peptide
CONFIDENTIAL 9
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalVALUE PROPOSITION:
LOW ENTRY COST FOR OPPORTUNITY TO LEAD THE
MIGRAINE ADVANCED TREATMENT MARKET
LCT Neurology Advisory Board conclusions:
Future lies in combination therapies
Need for acute parenteral treatments for severe events
That aborts the progression of the migraine attack “process”
Followed by “maintenance /preventative” treatment with
small molecule gepants, CGRP antibody or botox
Commercial Opportunity
Provider of initial acute treatment will have greatest
influence on choice of maintenance/preventative
treatment ie. disease management.
CONFIDENTIAL 10
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalCOVID-19 REVISED MILESTONES
Comparison of CGRP8-37 (LC-001) with LC-002
1) Rodent study to determine in vivo pharmacokinetic
parameters of LC-002 in comparison with CGRP8-37.
a. Surgery and subcutaneous dosing in 6 animals in each
3 months
group, plus 3 for a vehicle control group; male rats only
b. Measurement of the peptide in blood samples from a.
5 months
and data analysis
2) I n vivo dose-ranging/duration blood flow study in
rodents using laser doppler imaging, using LC-002 in
comparison with CGRP8-37 and vehicle.
a. Dosing of 6 animals per group; males only, 3 doses per Commencing after
group, and data analysis completion of 1a.
Surgeries, with
completion in 3 months
CONFIDENTIAL 11
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalLC-002 WORK FLOW
• Mouse target engagement
Work flow: model
• Capsaicin-Induced Dermal
Chemical I n vitro I n vivo target
Vasodilation (CIDV)
synthesis receptor engagement
• Gold standard model for
screen CGRP blockade
• Translatable to humans
Topical
Capsaicin
CGRP antagonist
reduces CIDV by CGRP
Release
blocking CGRP
Vasodilation
receptor binding Capsaicin
(Laser Doppler
Receptor
on blood vessels (TRPV1)
imaging)
CONFIDENTIAL 12
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalPRE-CLINICAL DATA
(Work in progress)
Developed a HPLC/MS analytical technique that
measures nanomolar concentrations in plasma
Initial data indicates LC-002 blood levels can be
measured and LC-002 can block capsaicin induced
vasodilation
Onset/duration studies in progress
CONFIDENTIAL 13
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalFUNDING POSSIBILITIES
Non Dilutive – Callaghan and Tax Rebates
Debt Equity
Investment
CONFIDENTIAL 14
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalOUT-LICENSE INTEREST
MIGRAINE
Investor and Company Feedback
All agreed valid target
All wanted clinical data
Expand pipeline – increase efficacy and combo
But – no face-to-face meetings
No new project decisions during lockdown
CONFIDENTIAL 15
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalLP-003 FOR OBESITY
CONFIDENTIAL 16
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalALL DIETS FAIL DUE TO HUNGER:
LP-003 INJECTIONS BLOCKS CNS HUNGER CENTRE
Market need
1.9 billion overweight
Morbid obesity treatment
Pramlintide (Symlin®)
FDA approved for diabetes in conjunction with insulin
Known safety profile; mimics natural actions of amylin
Obesity patients treated with Pramlintide lose weight
Mechanism is reduced food intake
Short duration of effect – requires three times daily
injections
CONFIDENTIAL 17
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalLONG ACTING PRAMLINTIDE
PRODUCT OPPORTUNITY IN OBESITY
Longer-acting Pramlintide analogue
Patented
Once Daily subcutaneous injection
Opportunity for combination therapy
e.g. with GLP-1 receptor agonists
Lipidation as a strategy
Lipidated (palmitate) GLP-1 agonist
Extended Plasma Half-life:
Albumin Binding
Protection for Protease Degradation
CONFIDENTIAL 18
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalLP-003 – ANTI-OBESITY: PRECLINICAL
PROGRESS TOWARDS HUMAN CLINICAL TRIALS
Progress
Prioritisation of lead peptide candidates
comment
Synthesis of next generation leads designed to improve receptor selectivity and/or
Completed
potency/solubility
In vitro pharmacology at amylin and related receptors of all synthesised peptides to determine
Completed
potency
Single dose comparison in vivo rodent body weight study, comparing three lipidated pramlintides
Completed
vs. pramlintide
Dose-ranging in vivo body weight rodent study LP-003 Completed
Dose-frequency in vivo rodent study to determine treatment duration vs. pramlintide paused
Development of peptide drug measurement assay initiated
Rodent study to determine in vivo pharmacokinetic parameters of one or more lipidated peptides
initiated
compared to pramlintide
Biomarker in vivo rodent study with lead lipidated pramlintide (s). Study will determine blood
not started
biomarkers (e.g. leptin) that may be useful in clinical studies.
Physicochemical properties study i.e. solubility, aggregation properties of lead lipidated peptides initiated
CONFIDENTIAL 19
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalLP-003 – ANTI-OBESITY: PRECLINICAL
PROGRESS TOWARDS HUMAN CLINICAL TRIALS
Mouse studies
High fat feeding so mice are obese
Once daily subcutaneous dosing of LP-003
Monitor food intake and body weight
LP-003 dose-dependently reduces food intake
and body-weight gain
CONFIDENTIAL 20
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalPUBLICATIONS AND PATENTS
Brimble MA, Harris P.W.R, Yule L, Hay D.L, Tups A, PCT Application Filed 08
May 2020, Peptide Conjugate Amylin Agonists and Uses Thereof. US Patent
Application 34772US01
Yang S-H, Harris PWR, Williams GM, Brimble MA. Lipidation of Cysteine or
Cysteine‐Containing Peptides Using the Thiol‐Ene Reaction (CLipPA). Eur. J.
Org. Chem.2016, 2608–2616
Brimble MA, Dunbar PR, Williams GW, Verdon D. Amino Acid and Peptide
Conjugates and Uses Thereof. PCT International Patent WO2016/103192 30
Jun 2016. (Application Number PCT/IB2015/059901, filed 22 Dec 2015)
United States Patent Application 15/535,956, 2018, Published 04 Jan 2018
CONFIDENTIAL 21
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalDRAFT CLINICAL TRIAL DESIGN
Design
Randomised, double-blind, placebo-controlled cross-over
Overnight fast
Single subcutaneous injection and standardised pre-load
meal
Ad libitum buffet meal offered one hour later
Total calorie intake and meal duration measured
Single Ascending Doses
6 x LP-003 and 2 x Placebo per cohort
CONFIDENTIAL
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalPROGRAMME PRIORITY
Migraine target priority – closer to clinic, pharma
company interest
Obesity milestones delayed but achievable
Pharmacokinetic study needed
Complete pre-clinical then if positive data phase 1 clinical
Obesity Advisory Board
CONFIDENTIAL 23
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalNTCELL® FOR PARKINSON’S DISEASE
CONFIDENTIAL 24
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalNTCELL FOR PARKINSON’S DISEASE
Large numbers needed to overcome individual data
variability
30 treated vs 30 placebo
Not possible in New Zealand
Needs very large investment
Need approvable GMP manufacturing facility
At least 3-year follow-up
5-year project
CONFIDENTIAL 25
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalFUNDING POSSIBILITIES
Non Dilutive Grant
Regional Out-license
Merger & Acquisition
CONFIDENTIAL 26
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalDIABECELL®
CONFIDENTIAL 27
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalDIABECELL® PROGRESS
DIATRANZ OTSUKA LIMITED (DOL)
DOL continued commitment to DIABECELL development
program in USA
Funding more than NZD 10million per year
Monkey safety and efficacy studies
Pre IND meeting FDA Feb 2021
LCT has 5% royalty on eventual product sales
CONFIDENTIAL 28
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalNEXT STEPS
CONFIDENTIAL 29
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalNEXT STEPS
LC-002 for Migraine
Complete pre-clinical in Q2 2021
Positive pre-clinical data Phase 1 Clinical in 2021
With positive clinical data target out-license in 2022
LP-003 for Obesity
Complete Pre-clinical in 2021
NTCELL for Parkinson’s disease
Out-license
CONFIDENTIAL 30
ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobalTHANK YOU
CONFIDENTIAL 31
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